An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210326
Company: FRESENIUS KABI USA

Products on NDA 210326

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210326

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210326s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210326Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210326Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210326s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210326Orig1s001, s002ltr.pdf
05/12/2021	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210326s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210326Orig1s001, s002ltr.pdf

Labels for NDA 210326

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210326s001s002lbl.pdf
05/12/2021	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210326s001s002lbl.pdf
05/20/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210326s000lbl.pdf

Therapeutic Equivalents for NDA 210326

FULVESTRANT

SOLUTION;INTRAMUSCULAR; 250MG/5ML (50MG/ML)
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FASLODEX	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	Yes	AO	021344	ASTRAZENECA
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	211689	ACCORD HLTHCARE
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	215077	ALEMBIC
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	210044	AMNEAL
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	211422	CHIA TAI TIANQING
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	209246	DR REDDYS
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	210326	FRESENIUS KABI USA
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	207754	GLENMARK PHARMS
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	209714	HBT LABS INC
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	214682	JIANGSU HANSOH PHARM
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	205871	SAGENT PHARMS INC
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	205935	SANDOZ
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	213553	XIROMED
FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION;INTRAMUSCULAR	Prescription	No	AO	215234	ZYDUS PHARMS

Top